A Study to Assess Bioquivalence Between a Novel Naproxen Sodium 275 mg Film-coated Tablet and Nalgesin Naproxen Sodium 275 mg Film-coated Tablet in Healthy Adult Volunteers

NCT03697889 | Completed Phase 1

• 1 other identifier: CO-171115092223-PACT
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

This is a research study designed to evaluate the rate and extent of absorption of Naproxen from a novel Naproxen sodium tablet and Nalgesin naproxen sodium 275 mg.

Conditions

Healthy

Keywords

Bioequivalence

Outcome Measures

Primary Outcomes (2)

• The maximum observed plasma concentrations (Cmax) of Naproxen Sodium

  The maximum observed plasma concentration (Cmax)

  15, 30, 45 minutes, and at 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours after drug administration

• The area under the plasma concentration-vs.-time curves from start of Naproxen sodium administration until the time of the last measurable concentration (AUCt)

  AUCt is defines as area under the plasma concentration versus time curves from start of drug administration until the last measureable concentration.

  15, 30, 45 minutes, and at 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours after drug administration

Secondary Outcomes (6)

• The area under the plasma concentration-vs.-time curve from the start of Naproxen sodium administration extrapolated to infinity (AUC∞)

  15, 30, 45 minutes, and at 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours after drug administration

• The extrapolated part of AUC∞, AUCExtrap

  15, 30, 45 minutes, and at 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours after drug administration

• The time at which maximum Naproxen sodium concentraton (Cmax) is observed (Tmax)

  15, 30, 45 minutes, and at 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours after drug administration

• The terminal elimination rate constant (lambda-z) for Naproxen sodium

  15, 30, 45 minutes, and at 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours after drug administration

• The terminal elimination half-life (t1/2) of Naproxen sodium

  15, 30, 45 minutes, and at 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours after drug administration

Study Arms (2)

Treatment Sequence AB

EXPERIMENTAL

Participants will receive Treatment A (test product Naproxen sodium tablet, 1 x 275 mg) at dosing period 1 followed by Treatment B (reference product Nalgesin, 1 x 275 mg) dosing period 2. There is a wash-out period of 7 days between the two dosing periods.

Drug: Naproxen sodium (test product); Drug: Naproxen sodium (reference product)

Treatment Sequence BA

EXPERIMENTAL

Participants will receive Treatment B (reference product Nalgesin, 1 x 275 mg) at dosing period 1 followed by Treatment A (test product Naproxen sodium tablet, 1 x 275 mg) at dosing period 2. There is a wash-out period of 7 days between the two dosing periods.

Drug: Naproxen sodium (test product); Drug: Naproxen sodium (reference product)

Interventions

Naproxen sodium (test product) DRUG

Participants will be administered single doses of 275 mg Naproxen sodium (test product) tablet orally.

Treatment Sequence AB; Treatment Sequence BA

Naproxen sodium (reference product) DRUG

Participants will be administered single doses of 275 mg Naproxen sodium (reference product - Nalgesin) tablet orally.

Also known as: Nalgesin

Treatment Sequence AB; Treatment Sequence BA

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male or female subject between the ages of 18 and 45 years, inclusive. Healthy is defined as the absence of any disease or abnormalities (including positive test for human immunodeficiency virus (HIV) 1 or 2 antibodies, hepatitis B surface antigen (HBsAg), or hepatitis C antibodies (anti-HCV) or syphilis (RW)) as judged by the investigator on the basis of a detailed medical history, physical examination, blood pressure, pulse rate measurements, 12-lead electrocardiogram, as well as clinical laboratory tests. The responsible investigator may request additional investigations or analyses if necessary
• Non- or ex-tobacco user, being defined as someone who completely stopped smoking or using any form of tobacco or nicotine-containing product for at least 12 months before 1st dose of the study drug in this study.
• Females: Postmenopausal state (absence of menstrual discharge for at least two years and a follicle stimulating hormone (FSH) serum level exceeding 30 IU/L) or premenopausal/perimenopausal state with an effective means of contraception (oral, injected, implanted, or transdermal hormonal contraceptives, vaginal contraceptive ring, intrauterine device, or status after operative sterilization) during the study and 30 days thereafter, single male partner who has had a vasectomy, or abstinence from heterosexual intercourse, during the study and 30 days thereafter.
• Males: No pregnant spouse or partner at screening and willingness to protect potential spouse or partner from becoming pregnant during the study and 30 days thereafter.
• Body Mass Index (BMI) ≥ 18.5 and ≤ 30.0 kg/m2 with a total body weight \>50 kg.
• A personally signed and dated informed consent document, indicating that the subject has been informed of all pertinent aspects of the study.
• Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures specified in the protocol.

You may not qualify if:

• Use of any vitamins, dietary and herbal supplements within 7 days before each dose of study drugs.
• Use of any nonprescription or prescription medications, including naproxen medications, other than contraceptives, within 5 times the drug's half-life before each dose of study drug.
• Depot injection or an implant of any drug within 3 months prior to dosing.
• History of any allergy or hypersensitivity (e.g. skin reaction, asthma, angioedema) to naproxen, ibuprofen, ASA, other NSAIDs or any related products (including excipients of the formulations).
• Females: Confirmed pregnancy or a positive pregnancy test at the screening visit, or planning to become pregnant during the duration of the study, and/or breast-feeding
• Has a history of peptic ulcers, gastrointestinal bleeding of any etiology, bleeding disorders, gastrointestinal disease (including chronic heartburn or gastroesophageal reflux disease), inflammatory bowel disease (ulcerative colitis, Crohn's disease), or gastrointestinal surgery other than appendectomy.
• Has asthma, hypertension, fluid retention, or heart disease either by history or by the medically qualified principal investigator's medical judgment; has hemophilia and other disorders of blood clotting and hemostasis disorders, has cerebrovascular hemorrhage or other hemorrhages;
• Has renal or hepatic impairment; according to the medically qualified investigator discretion;
• Acute infectious disease within 4 weeks prior to screening.
• Treatment with an investigational drug within 3 months preceding the first dose of study treatment.
• Preplanned surgical procedures during the study period, if this may interfere with the conduct of the study.
• History of alcoholism defined as alcohol consumption in the 6 months before screening that exceeds weekly limits of 10 alcohol units (2 L of wine or 5 L of beer or 0.5 L of spirits) or substance abuse, as judged by the Investigator, within the past 6 months preceding this study.
• Consumed alcohol beverage(s) within 48 hours prior to the first scheduled dose of the study drug, positive respiratory alcohol test at screening, or inability to abstain from alcohol consumption during the entire study period.
• Positive urine screen for drug abuse.
• Use of xanthine containing products (e.g., coffee, tea, chocolate or cola drink) within 48 hours before each dose of study drug.

Sponsors & Collaborators

• McNeil AB: lead

Study Sites (1)

LLC "Scientific and Research centre Eco-safety"

Saint Petersburg, 196143, Russia

Location

Related Links

• Synopsis to support result registration for a clinical study performed within the Russian federation.

MeSH Terms

Interventions

Naproxen

Intervention Hierarchy (Ancestors)

Naphthaleneacetic Acids; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Konstantin A. Zacharov, MD

  LLC "Scientific and Research centre Eco-safety"

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2018
• First Posted: October 5, 2018
• Study Start: December 3, 2018
• Primary Completion: December 17, 2018
• Study Completion: January 21, 2019
• Last Updated: January 23, 2020

Record last verified: 2020-01

Locations

RU (1)